DEVICE: Easy@Home Multi-Drug Screen Test (10 tests kit) (00810038631684)

Device Identifier (DI) Information

Easy@Home Multi-Drug Screen Test (10 tests kit)
EDOAP-754
In Commercial Distribution
EDOAP-754-10
EASY HEALTHCARE CORPORATION
00810038631684
GS1

10
080278407 *Terms of Use
10 tests kit;5-Panel Dip Card; AMP/BZO/COC/OPI/THC
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46994 Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DKZ Enzyme Immunoassay, Amphetamine
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DJG Enzyme Immunoassay, Opiates
JXM Enzyme Immunoassay, Benzodiazepine
LDJ Enzyme Immunoassay, Cannabinoids
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K133968 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

91061cad-caba-48af-bb40-d27c74739808
July 25, 2022
3
October 28, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10810038631681 60 00810038631684 2021-10-22 Not in Commercial Distribution Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 30810038631685 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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